Devices

Device Recall Spacelabs ARKON Anesthesia Workstation

Model / Serial
ARKN-000001, ARKN-000005, ARKN-000010, ARKN-000015, ARKN-000016, ARKN-000017, ARKN-000018, ARKN-000020, ARKN-000021.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian.
Product Description
Spacelabs ARKON Anesthesia Workstation. || Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.
Manufacturer
Del Mar Reynolds Medical, Ltd.
1 Event
- Recall of Device Recall Spacelabs ARKON Anesthesia Workstation

Manufacturer

Del Mar Reynolds Medical, Ltd.

Manufacturer Address
Del Mar Reynolds Medical, Ltd., 1-2 Harforde Ct., Foxholes, Business Park, Hertford United Kingdom
Manufacturer Parent Company (2017)
OSI Systems Inc
Source
USFDA

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